GRA Device Lead; Associate Director - Digital Health

Job Title: GRA Device Lead (Associate Director) - Digital Health

Location: Cambridge, MA / Morristown, NJ

About the Job

GRA Device Lead (Associate Director) - Digital Health

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.

The Global Regulatory Affairs (GRA) Device team is a globally diverse team supporting the medical device, combination product, digital health and in‑vitro diagnostic (IVD) products within the Sanofi portfolio. The team is part of the GRA CMC & GRA Device Department within Global R&D. The GRA Device organization serves as a critical strategic partner within Sanofi's regulatory framework, providing expert guidance on medical device regulatory requirements across the product lifecycle.

Our department bridges technical development, manufacturing operations, and global regulatory authorities to ensure compliance while optimizing product approval pathways. The team develops and implements global regulatory strategies for device and IVD products, leading regulatory efforts in development and post‑marketing stages.

As GRA Device Lead in the GRA Device Digital and Diagnostic team you’ll drive global regulatory strategies for medical device and digital health technologies, collaborate with cross‑functional teams, optimize product development and manufacturing processes, and directly influence the success of product approvals through strategic negotiations with health authorities worldwide.

The GRA Device Lead role is critical and highly visible; it supports a wide range of digital health technologies (DHTs) from digital biomarkers, wearables, software as a medical device (SaMD), connected devices, and other innovative technologies. Working at the intersection of science and compliance, you will develop device strategies, conduct risk assessments, and serve as the primary liaison with regulatory authorities, collaborating across R&D, Device, Manufacturing, and Quality teams while preparing high‑quality regulatory submissions, managing compliance, and anticipating regulatory trends.

About Sanofi:

We’re an R&D‑driven, AI‑powered biopharma company committed to improving people’s lives. Our deep understanding of the immune system and innovative pipeline enable us to invent medicines and vaccines that treat and protect millions worldwide. Together, we chase the miracles of science to improve people’s lives.

• Serve as GRA Device Lead for DHTs and SaMDs on assigned project teams (early phase, late stage and marketed products)
• Provide regulatory guidance and advice to the Global Regulatory Team (GRT) and cross‑functional teams
• Develop and execute innovative and sustainable medical device regulatory strategies covering DHT, digital biomarkers/endpoints, and SaMD elements
• Define device Health Authority interactions plan, lead device‑related Health Authority interactions, and support cross‑functional Health Authority interactions
• Identify DHT regulatory acceleration opportunities and regulatory risks, and propose thoughtful risk mitigations in collaboration with the GRT
• Identify and manage issues and opportunities that impact submission timelines; ensure appropriate communication, resolution and/or escalation as needed
• Lead global filing and lifecycle management activities for device submissions/device aspects of medicinal product submissions
• Liaise with device, clinical, manufacturing, commercial, and other internal business partners to enable successful regulatory outcomes
• Prepare, review and approve design control deliverables
• Contribute to product development and lifecycle management planning; provide regulatory impact assessments for proposed product changes
• May serve as a regional/local regulatory lead and point of contact with Health Authorities for projects/products in their remit, as needed
• Participate in development and monitoring of the global regulatory environment and update standards and processes related to device regulations
• Contribute to a harmonized One Sanofi regulatory voice through participation in…